Reported Aug 18, 2021 · Terminated
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F,…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards PediaSat Oximetry Catheter Kit
- REF
XT358SJUsable Length 8 cmNumber of Lumens 3Exterior Diameter 5.5FRx OnlySterile EO
- UDI(01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
- Lot codes and dates
- LOT NUMBERS
6237464962489899625057636254466262728572628890536304588463080087631056216317648263256056632662496335087363374025
- LOT NUMBERS
- Amount recalled
- 218 UNITS
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential for internal leaks within catheters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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